•Many Medical Device Manufactures are referencing ASTM F as the visual inspection method they use to verify the sterile barrier integrity of their packaging . ASTM F testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in . Designation: F – 98 (Reapproved ) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual.
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ASTM-F – Medical Package Testing
The width of package seals need to be compared to individually de? Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and? For more information visit www. Insufficient sealing temperature either too much, too little, or unevenly applied pressure; too short a process time; adtm, excessive material thickness variation are some of the conditions that may cause seals to appear to be spotty or mottled.
Seal attributes can be atsm linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity. ASTM-F Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Atsm Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity.
In such cases, an additional physical seal f886 test may be required to con? Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi?
Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. Causes for channels have been discussed above in X1.
Mark the location of the channels. These types of characteristics often are hard to judge by visual inspection alone and need to be further evaluated by alternate means such as dye penetration. In some instances, a channel or unsealed area may be observed only after the package is peeled open.
Visual seal defects will often be the initial indication of heat sealing process variation. The visual characteristics of a package that has never been sealed versus one that has been sealed, and subsequently opened, are very different, and depend on the material substrates being examined.
It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Precision and Bias 3 8. Current edition approved June 1, Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. It is possible to have continuous seal integrity but fail to give complete transfer. Seal creep may be a result of the sterilization process or stressed seals at temperature extremes.
ASTM F (Reapproved )_百度文库
A superscript epsilon e indicates an editorial change since the last revision or reapproval. Generally, this occurs with? Completeness and uniformity of the entire seal area of the package must be inspected. These too can result in a channel through the entire seal. Impact also may cause the seals to partially rupture. Any part of the seal where channels appear across entire seal width must be identified and recorded.
ASTM F1886/F1886M – 16
Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.
A statistical analysis of the data by means of a contingency table show signi?
Visual inspection may or may not detect tears or pinholes. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Size of channel Degree of contrast from sealed and unsealed areas Amount and type of adhesive between the two package layers Reflecting light angle Types of materials used Use of magnification ASTM F procedure is comprised of the following: This is because the coating f186 have f188 stronger affinity for the substrate on which it is coated rather than the one to which it is sealed.
The four different types of medical device packages are: Last previous edition approved in as F — If you feel that your comments have not received a zstm hearing you should make your views known to the ASTM Committee on Standards, at the address shown below.